BEUDAMED
    FDA Adverse Event Summary report: N

    3080SP SURGICAL TABLE

    MDR report key: 6064943 · Received October 28, 2016

    Report

    Report Number
    1043572-2016-00087
    Date Received
    October 28, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 28, 2016
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ON-SITE, INSPECTED THE TABLE, AND IDENTIFIED THAT THE BOLTS WHICH SECURE THE TILT CYLINDER TO THE TABLE WERE NOT FULLY ENGAGED AND REQUIRED REPLACEMENT. THE 3080SP SURGICAL TABLE WAS MANUFACTURED IN 1995 AND HAS BEEN IN SERVICE FOR 21 YEARS. THE STERIS TECHNICIAN NOTIFIED THE USER FACILITY THAT THE TABLE SHOULD BE REMOVED FROM SERVICE PENDING TABLE REPLACEMENT. THE FACILITY'S STERIS ACCOUNT MANAGER IS WORKING WITH THE USER FACILITY REGARDING REPLACEMENT OPTIONS FOR THE TABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR 3080SP SURGICAL TABLE TILTED WHEN TRANSFERRING A PATIENT OFF THE TABLE AFTER CONCLUSION OF A PROCEDURE. NO INJURY, PROCEDURE DELAY, OR CANCELLATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714080 3080SP SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1